Are There Any New Medications for ADHD?

Summary: Yes, the FDA recently approved a new medication for ADHD – attention-deficit hyperactivity disorder (ADHD) – for treatment and support of children, adolescents, and adults.

Summary:

• A series of clinical trials in people ages 6 and up demonstrated the safety, effectiveness, and tolerability of a new medication called centanafadine.
• Based on this evidence, the U.S. Food and Drug Administration (FDA) approved the new medication for ADHD on July 24^th, 2026.
• When government agencies finalize the scheduling process in the coming months, centanafadine will be available under the brand name Simtriyo.
• This is the first approved ADHD treatment in a class of medications that inhibit reuptake of serotonin, norepinephrine, and dopamine, known as SNDRIs.

New Medication for ADHD May Have Multiple Benefits

Centanafadine is a triple reuptake inhibitor and a central nervous system stimulant. As a stimulant, it resembles previously approved, well-known ADHD medications. However, clinicians see potential benefit for this medication beyond ADHD: it may help people with co-occurring ADHD and anxiety disorders, such as generalized anxiety disorder (GAD) and social anxiety disorder (SAD).

In a webinar hosted by the online ADHD-focused news publication ADDitude, Dr. Greg Mattingly observes:

“Centanafadine is another way to get serotonin and was shown to help anxiety and mood in people with ADHD since it kind of has an SSRI built in.”

That’s a promising outcome and shows potential multi-purpose use for this new medication in the future. However, for now, in the short-term, this medication will be available for patients ages 6 and up, weighing at least 44.1 pounds (20 kg), with a clinical diagnosis of attention-deficit hyperactivity disorder (ADHD).

The FDA approval – read the press release here – is the result of data from three trials on the medication in three separate populations: children, adolescents, and adults. Here’s how the manufacturers of the drug describe its action, i.e., how it works:

“By inhibiting the reuptake of norepinephrine, dopamine, and serotonin, SIMTRIYO increases the availability of these neurotransmitters in pathways involved in attention and behavioral regulation.”

And here’s how they describe the two recent studies that led to approval by the FDA:

“In a recently completed [trials] in adults with ADHD and comorbid anxiety, centanafadine demonstrated statistically significant improvements in ADHD symptoms compared with placebo, providing additional insight into its clinical profile.”

In the rest of this article, we’ll describe those two studies, as well as the initial study which led to the recent FDA decision. We’ll start with the results for children, then report the results for adolescents, and end with the results for adults. We’ll focus on ADHD outcomes, rather than anxiety outcomes, which will be available over the next several months.

What Evidence Resulted in Approval of Centanafadine, a New Medication for ADHD?

In late July 2025, a group of researchers published a study called “Efficacy and Safety of Centanafadine for ADHD Treatment in Children: A Randomized Clinical Trial,” which they describe as follows:

“This randomized, double-blind, placebo-controlled clinical trial evaluated the efficacy, safety, and tolerability of centanafadine (CTN) vs placebo in children with ADHD.”

The research team recruited 480 participants with ADHD and randomly assigned them to one of three groups:

• Low-dose CTN: 154
• High-dose CTN: 162
• Placebo: 164

All participants completed the ADHD Rating Scale-5 (ADHD-RS-5) at the beginning of the study to establish a baseline, then received medication or placebo once daily for six weeks, repeating the ADHD RS-5 once a week for the duration of the study. At the study endpoint, six weeks after initiation, patients in the high-dose CTN showed statistically significant superiority to placebo on the ADHD-RS-5 metric.

Here’s what the data showed:

• High-dose CTN: 16.3 point improvement after six weeks
• Placebo: 10.8 point improvement after six weeks

The research team concluded:

“High-dose CTN was efficacious for treatment of ADHD in children. Both CTN doses were safe and well tolerated.”

That’s the data for children. It’s promising because it gives clinicians another tool to support children with ADHD, and families an additional option when considering ADHD treatment for their child.

Now let’s look at the data for adolescents, which was collected and analyzed in a separate study.

Data for Adolescents: Similar Outcomes

In early July 2025, the same group of researchers published a study called “Centanafadine for Attention-Deficit/Hyperactivity Disorder in Adolescents: A Randomized Clinical Trial,” which they describe as follows:

“[We] evaluated the efficacy, safety, and tolerability of centanafadine, a norepinephrine, dopamine, serotonin reuptake inhibitor-in the treatment of attention-deficit/hyperactivity disorder (ADHD) in adolescents.”

The team recruited 459 adolescents 13-17 years with a clinical ADHD diagnosis and randomly assigned to one of three groups:

• Low-dose CTN: 155
• High-dose CTN: 155
• Placebo: 149

In a protocol similar to the study on children, study participants completed the ADHD Rating Scale-5 (ADHD-RS-5) at the beginning of the study to establish baseline values for comparison, then received medication or placebo once daily for six weeks. Like the study on children, participants completed the ADHD RS-5 once a week for the duration of the study. At the study endpoint, six weeks after initiation, patients in the high-dose CTN showed similar results as in the study on children: high-dose  centanafadine outperformed placebo on the ADHD-RS-5 metric, with statistically significant improvement in ADHD symptoms.

Here’s what they found:

• High-dose CTN: 18.5 point improvement after six weeks
• Placebo: 14.5 point improvement after six weeks

Here’s how the research team characterized their findings:

“Centanafadine [high-dose] was efficacious for ADHD treatment in adolescents… [and] both doses were generally safe and well tolerated.”

Now let’s look at the data for adults, collected and analyzed in a third study, performed several years ago.

Data for Adults: Similar Results, Foundation of Approval

In October 2022, a different team of researchers published the results of a study called “Efficacy, Safety, and Tolerability of Centanafadine Sustained-Release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder,” which created the evidentiary basis for the two recent studies that led to full FDA approval.

Here’s how that first group of researchers introduced the medication and their research effort:

“Centanafadine is an inhibitor of norepinephrine, dopamine, and serotonin reuptake transporters under investigation for the treatment of attention-deficit/hyperactivity disorder (ADHD).”

To test its clinical effectiveness, the research team conducted two separate trials, each including over 500 adults with a clinical diagnosis of ADHD. Participants were randomly assigned to one of three groups:

• Low-dose CTN: ~150-175 per trial
• High-dose CTN: ~150-175 per trial
• Placebo: ~150-175 per trial

All participants completed the Adult ADHD Investigator Symptom Rating Scale (AISRS) and the Clinical Global Impression–Severity of Illness Scale (CGI-SIS) at the beginning of the study, then received medication or placebo once daily for six weeks. Participants completed both metrics once a week for 42 days total, i.e. 6 weeks. At the end of the study, patients in both dosage groups CTN showed statistically significant superiority to placebo on the AISRS and the CGI-SIS.

Here’s what they found:

Study One: ADHD in Adults

• Low-dose CTN:
  • AISRS: 10.13 point reduction
  • GCI-SIS: 0.78 point improvement from baseline
• High-dose CTN:
  • AISRS: 9.73 point reduction
  • CGI-SIS: 0.79 point improvement from baseline
• Placebo:
  • AISRS: 6.93 point reduction
  • CGI-SIS: 0.52 point improvement from baseline

Study Two: ADHD in Adults

• Low-dose CTN:
  • AISRS: 12.08 point reduction
  • GCI-SIS: 1.04 point improvement from baseline
• High-dose CTN:
  • AISRS: 12.49 point reduction
  • 99 point improvement from baseline
• Placebo:
  • AISRS: 8.07 point reduction
  • GCI-SIS: 0.71 point improvement from baseline

Here’s how they summarized these results:

“Centanafadine was associated with improvements across measures of executive function compared with placebo, as assessed by the Executive Functioning subscale of the Adult ADHD Self-Report Scale (ASRS) Expanded Version. Both centanafadine dose groups demonstrated statistically significant and clinically meaningful improvements versus placebo.”

We’ll discuss these results and the approval of this new medication for ADHD below.

New ADHD Medication: Effective For ADHD, May Have Potential for ADHD + Mental Health Disorders in Future

Millions of children, adolescents, and adults in the U.S. have a clinical diagnosis of ADHD.

Among adults, the most recent estimates show:

• 18-24: 21.7%
• 25-49: 62.8%
• 50-64: 10.6%
• 65+: 4.9%

Among children and adolescents, the most recent estimates show:

• 3-5: 2.3%
• 6-11: 11.1%
• 12-17: 13.6%

In addition, the non-profit organization Children and Adults with Attention Deficit/Hyperactivity Disorder (CHADD) shows that co-occurring mental health disorders/conditions among people with ADHD are common:

• Total co-existing/occurring disorder or condition: 67%
• Behavioral disorders: 40%
• Mood disorders:
  • Adults: 38%
  • Children/adolescents: 14%
• Anxiety:
  • Adults: 53%
  • Children/adolescents: 30%

The most effective treatment for ADHD in children, adolescents, and adults is a combination of medication, therapy, counseling, behavioral coaching, and lifestyle changes. However, the presence of co-occurring mental health issues, such as anxiety or depression, can complicate the treatment process and have a negative impact on ADHD symptom improvement. While this new medication for ADHD is not yet approved for anxiety, the potential is real. Since it’s what scientists call an SNDRI – a serotonin, norepinephrine, and dopamine reuptake inhibitor – it increases the amount of chemicals in the brain associated with improvement in anxiety and depression.

As we mention above, that’s promising news. Not only does this medication show improvements for ADHD symptoms across age group, data shows it also may help patients with co-occurring anxiety. In the short-term, this medication may help improve ADHD treatment, and in the long run, may help improve treatment for ADHD and additional, co-occurring mental health issues.